Sentrant™ SENSH1264WRecalls & reported problems
Medtronic, Inc. · SHEATH SENSH1264W Sentrant Hydr EtO eIFU · Class 2
All models of Sentrant (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169792654), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Damaged by Another Device1
Patient problems
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2019Device Damaged by Another Device; Device Damaged by Another Device
A SENTRANT SHEATH WAS USED AS A CONDUIT FOR AN ENDURANT DEVICE DURING EVAR FOR A RUPTURED 70MM ABDOMINAL AORTIC ANERUYSM. IT WAS REPORTED THE PATIENT HAD A SHORT NECK. IT WAS REPORTED DURING THE INDEX PROCEDURE THE ENDURANT LIMB BECAME STUCK IN THE SHEATH DURING WITHDRAWAL. THE FEMORAL ARTERY HAD TO BE SURGICALLY EXPOSED AND THE SHEATH HAD TO BE ¿CUT AWAY¿ FROM THE LIMB TO BE REMOVED. THE SHEATH WAS REPLACED WITH A NEW 16 FR SENTRANT SHEATH AND PROCEDURE WAS COMPLETED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
Patient problems: Injury
MAUDE report 9261023 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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